The FDA has approved olaparib (Lynparza®, AstraZeneca) for the adjuvant treatment of patients with deleterious or suspected deleterious germline BRCA–mutated, human epidermal growth factor receptor 2 (HER2)–negative high-risk early breast cancer who have previously received adjuvant or neoadjuvant chemotherapy. Olaparib is a poly–adenosine diphosphate ribose polymerase (PARP) inhibitor and is the first approved medication targeting BRCA mutations in early breast cancer. "Approximately 5% of unse...

Olaparib prolongs overall survival compared with enzalutamide or abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) and gene alterations in BRCA1, BRCA2, or ATM, according to the final survival analysis of the phase 3 PROfound trial. These results were presented yesterday at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and simultaneously published in the New England Journal of Medicine. "Metastatic castration-resistant prostate cancer r...

Last weekend, in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, Andrés Poveda, MD, presented results of the phase 3 SOLO2/ENGOT Ov-21 trial, reporting that olaparib significantly increased median overall survival compared with placebo in patients with platinum-sensitive BRCA-mutated relapsed ovarian cancer. In this interview with i3 Health, Dr. Poveda, Executive Co-Director of Initia Oncology in Valencia, Spain, discusses the significance of the trial's results...

In patients with platinum-sensitive BRCA-mutated relapsed ovarian cancer, olaparib maintenance therapy significantly increased median overall survival compared with placebo, according to results of the final analysis of the phase 3 SOLO2/ENGOT Ov-21 trial to be presented this coming weekend in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program. The trial enrolled 295 patients with BRCA-mutated relapsed ovarian cancer who were previously treated with at least two lin...

The FDA has approved olaparib (LynparzaTM, AstraZeneca Pharmaceuticals LP) for adult patients with homologous recombination repair (HRR)–mutated metastatic castration-resistant prostate cancer (CRPC) who experience disease progression after treatment with enzalutamide or abiraterone acetate. In addition, the FDA approved two companion diagnostic devices: FoundationOne® CDx (Foundation Medicine, Inc.), for the identification of HRR gene alterations, and BRACAnalysis CDx®(Myriad Genetics, Inc...

Olaparib (Lynparza®, AstraZeneca Pharmaceuticals, LP), in combination with bevacizumab (Avastsin®, Genentech), is now FDA approved as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have had a complete or partial response to first-line platinum-based chemotherapy. Patients must also have cancer that is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or ...

A phase 3 trial reports that olaparib as maintenance therapy in combination with bevacizumab increases progression-free survival (PFS) in patients with newly diagnosed, advanced high-grade ovarian cancer both with and without BRCA mutations. While previous studies have found that maintenance olaparib is associated with improved outcomes in patients with ovarian cancer with BRCA mutations, its efficacy in patients without BRCA mutations had not been confirmed. In the phase 3 PAOLA-1 trial, a team...

The FDA has now approved olaparib (Lynparza®, AstraZeneca) for the maintenance treatment of adults with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma who have not experienced disease progression after at least 16 weeks of a first-line platinum-based chemotherapy regimen. In addition, the FDA approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) as a companion diagnostic for the selection of patients with deleterious or suspected ...

Poly(ADP)-ribose polymerase (PARP) inhibition is a new form of targeted therapy that has exhibited effectiveness in treating several solid tumor types. Olaparib (Lynparza®, AstraZeneca), rucaparib (Rubraca®, Clovis Oncology), and niraparib (Zejula®, Tesaro) have all been approved for the treatment of advanced ovarian cancer. Olaparib has also been approved to treat BRCA-mutated breast cancer and is currently being investigated in the treatment of prostate cancer. Another PARP inhibitor, talazopa...

The FDA has now approved olaparib (Lynparza®, AstraZeneca Pharmaceuticals LP) for maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer experiencing complete or partial response to first-line platinum-based chemotherapy. Patients are to be selected for therapy using an FDA-approved companion diagnostic, the BRACAnalysis CDx® test (Myriad Genetic Laboratories, Inc.). The ...

The phase 3 POLO trial (NCT02184195) reports that maintenance olaparib increases progression-free survival in metastatic pancreatic cancer with germline BRCA mutations. "Metastatic pancreatic cancer is particularly refractory to treatment," Talia Golan, MD, Head of the Sheba Pancreatic Cancer Center at the Oncology Institute of Tel Aviv University's Sheba Medical Center, and colleagues remark in their publication in The New England Journal of Medicine. "Current standard-of-care first-line t...